510(k) · Cleared
Recalled · Class I · 2014Heart Sync, Models C-100 and T-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Sync, LLC · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 29, 2008 as substantially equivalent to K020203 (Padpro, LLC, 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1998. 2 of the 7 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 11 times, including 5 Class I recalls.
- Decided
- Feb 29, 2008
- Review
- 14 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 11 (5 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981737 (1998). 4 later devices descend from it, 4 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK981737 K-Defib/Pace Adult Electrode Model Number KDP-60Katecho, Inc. · 1998
- 1 generation backK020203 Padpro Model #2516Padpro, LLC · 2002 · Recalled (Class I)
- This deviceK080421 Heart Sync, Models C-100 and T-100Heart Sync, LLC · 2008
- Descendant · cites it directly · 0 of its ownK131550 Heart SyncHeart Sync, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK103783 Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro…Fiab Spa · 2011
- Descendant · cites it directly · 0 of its ownK103334 Cardio MedCardio Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK103159 Cardio Med Model A102, H104, O101, P103, and Z100Cardio Medical Products, Inc. · 2011 · Recalled
Class I recalls in this family
- K020203 Padpro Model #2516direct predicate · 2002
Most influential descendants
Showing 4 of 4 · See all- K131550Heart SyncHeart Sync, Inc. · 2013 · cites it directly0descendants
- K103783Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricFiab Spa · 2011 · cites it directly0descendants
- K103334Cardio MedCardio Medical Products, Inc. · 2011 · cites it directly0descendants
- K103159Cardio Med Model A102, H104, O101, P103, and Z100Cardio Medical Products, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60 | Katecho, Inc. | 1998 | — |
| −1 | K020203 | Padpro Model #2516 | Padpro, LLC | 2002 | Class I |
| 0 (this device) | K080421 | Heart Sync, Models C-100 and T-100 | Heart Sync, LLC | 2008 | — |
| +1 | K131550 | Heart Sync | Heart Sync, Inc. | 2013 | — |
| +1 | K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads… | Fiab Spa | 2011 | — |
| +1 | K103334 | Cardio Med | Cardio Medical Products, Inc. | 2011 | — |
| +1 | K103159 | Cardio Med Model A102, H104, O101, P103, and Z100 | Cardio Medical Products, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020203 | Padpro Model #2516Summary page 1…rocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode 2. Equivalent legally marketed devices: This is identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design. 3. Indications for Use: The Heart Sync Adult Radio Transparent and/or Transluce… | 2002 |
| * | K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60Summary page 1…nction; MLN Common/Usual Name: Defibrillator Electrode 2. Equivalent legally marketed devices: This is identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design. 3. Indications for Use: The Heart Sync Adult Radio Transparent and/or Translucent Multi Function El… | 1998 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2014 | Class I | Z-0584-2015 | Device Design | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads… |
| Nov 11, 2014 | Class I | Z-0585-2015 | Device Design | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads… |
| Nov 11, 2014 | Class I | Z-0583-2015 | Device Design | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads… |
| Nov 11, 2014 | Class I | Z-0586-2015 | Device Design | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads… |
| Nov 11, 2014 | Class I | Z-0587-2015 | Device Design | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads… |
| Apr 26, 2013 | Class II | Z-1434-2013 | Process design | On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012.… |
| Apr 26, 2013 | Class II | Z-1435-2013 | Process design | On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012.… |
| Dec 17, 2010 | Not classified | Z-1372-2011 | Packaging | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may… |
| Dec 17, 2010 | Not classified | Z-1371-2011 | Packaging | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may… |
| Dec 5, 2008 | Not classified | Z-1950-2011 | Equipment maintenance | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| Dec 5, 2008 | Not classified | Z-1951-2011 | Equipment maintenance | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
The 5 latest of 11 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K020203Padpro Model #2516Padpro, LLC · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K131550 (Heart Sync, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K020203.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode…
Read the full statement (125 words)
The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080421: Heart Sync, Models C-100 and T-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080421
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026